The World Health Organization (WHO) has issued a publication outlining key regulatory considerations for artificial intelligence (AI) in health. This guidance underscores the need for ensuring the safety and effectiveness of AI systems while promoting their rapid deployment to benefit those in need. It emphasizes fostering dialogue among stakeholders and highlights the importance of robust legal and regulatory frameworks to safeguard privacy, security, and integrity when using health data.
WHO recognizes the potential of AI to transform healthcare by enhancing clinical trials, medical diagnosis, and patient-centered care, particularly in regions with a lack of medical specialists. However, the guidance also acknowledges the ethical and regulatory challenges posed by AI in healthcare, including data privacy concerns and potential biases.
The publication outlines six areas for regulating AI in health, including transparency, risk management, external validation, data quality, compliance with existing regulations, and fostering collaboration among various stakeholders. It aims to provide principles that governments and regulatory authorities can use to develop or adapt their own AI guidelines and regulations at the national or regional level.